A Dose of Reality: Laboratories Need to be a Key Priority in Companion Diagnostics

August 2nd, 2012

Mark Reis

Mark Reis highlights the Labceutics’ survey on the attitudes and behavior of labs in the EU5 which finds that pharma-lab communication is poor. He calls for pharma to give labs further discussion and analysis as new companion diagnostics and diagnostic tests come to market.

The Financial Times article, “Commercial Realities of Diagnostics,” by Andrew Jack, July 25, 2012, highlighted the fact that ‘home brew’ or laboratory developed tests (LDTs) developed in hospitals, universities and other labs are increasingly competing with test kits developed by diagnostic companies. This trend is all the more prevalent in the EU5 where the lab environment is highly fragmented and LDTs are seen as a way to have more control over the process. At the end of the day, if the focus is on quality, uniform standards and patient care, all stakeholders along the personalized medicine continuum will benefit.

This year’s Labceutics’ report (email info@www.diaceutics.com for a copy), which looked at the attitudes and behavior of labs in the EU5, demonstrated that the choice to purchase a kit versus developing an LDT was perceived as a profitability and quality issue. In fact, based on the survey, 40 per cent of laboratories had never purchased an IVD kit in some regions. This may in part be due to the fact that the business case and potential demand for kits hasn’t traditionally been well communicated to labs. Our survey indicated that less than 7 per cent of labs had ever been contacted by a pharmaceutical or diagnostic company to discuss a test they had available. This is an area that warrants more discussion and analysis as new companion diagnostics and diagnostic tests come to market. In today’s world of doing more with less, molecular diagnostic and genetic testing is providing labs with the opportunity to offer more profitable, novel diagnostics that will help differentiate their services, inform physician decisions and ultimately improve patient care. More information about this survey is available at info@www.diaceutics.com. The full survey results will be presented by Labceutics at the Molecular Diagnostics World Congress, September 25-26, San Diego, CA and the European Society for Medical Oncology, September 28 to October 2, Vienna, Austria [2012].

As personalized medicine and companion diagnostics become more prevalent in healthcare delivery, laboratories are taking on an increasingly important role — one that both pharmaceutical and diagnostic companies should be analyzing. Ensuring the appropriate sample handling, turnaround time, standards and quality, prescriber education and result interpretation, are all critical services the pathologist and laboratorian deliver on a daily basis. With guidelines evolving as we speak, it behoves all of the stakeholders in personalized medicine to better understand the role the lab plays in providing superior laboratory service that aligns the diagnostic with therapy.

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